The EU Medical Device Regulation (MDR) requires manufacturers to perform active Post-Market Surveillance (PMS). This means that manufacturers are required to collect and analyse the lifetime data of their devices and upload the data.
However, this requirement can pose intense difficulties for manufacturers whose devices are still largely analogue and depend largely on manual information gathering. CardiLink offers the opportunity to digitise and connect thousands of analogue medical devices in a secure, GDPR- and MDR-compliant manner.
This contributes to increasing uptime and the availability of medical devices, giving victims of SCA better odds of survival, and potentially saving tens of thousands of lives across the globe annually. It also enables manufacturers to offer their distributors better products, while permitting the latter to offer their customers an improved service concept.
CardiLink meets the HealthLevel 7 (HL7) ANSI-accredited standard for the exchange, integration, and sharing and retrieval of electronic health information.
Data validation Saves Lives
IoT readiness control of safety equipment: identifies and remedies unsafe situations
IoT equipment monitoring: renders manual check-ups redundant
GPS/cellular safety equipment movement tracking: provides 1st Responders with coordinates
Fleet Management via software tracking: reduces waste by extending economic life
Fleet Management of servicing & training: combines resource deployment, reducing costs
Automated tracking & status documentation: verifiable and measurable compliance of safety procedures and Medical Device Regulations
CardiLink is a customer-individualised and license-based Software as a Service (SaaS) product. If you want to learn more or register a device, please contact us and our team will be happy to evaluate your case.
